Medical Device and Diagnostic Industry (MD+DI)

FDA Removes Medical Device Application Review Barrier

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...
Fierce Biotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be ...
STAT

Key digital health and device leaders depart FDA

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...

FDA Provides Thought-Provoking System Life-Cycle Scenario Encompassing AI-Enabled Mental Health Devices

The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
Medical Device and Diagnostic Industry (MD+DI)

Will Simplified EU MDR Come with Free Therapy?

This week in Pedersen's POV, our senior editor finds humor in the European Commmission's plan to simplify the EU Medical ...

FDA scrutiny of WHOOP signals challenges for niche wearable device makers

The FDA's scrutiny of WHOOP highlights increasing challenges for niche wearable device makers as they navigate regulatory ...
MedTech Dive

FDA needs more staff, authority to oversee device recalls, watchdog finds

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...
Medical Device Network on MSN

What 2025 reveals about medtech’s next leap in 2026

No one can predict what the medical device industry will look like in 2026. Still, the events of 2025 provide meaningful ...
News Medical

Learn to navigate regulatory pathways for SaMD

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...